Mammogen, a Newport Beach-based diagnostics company, has raised up to $30 million in Series A financing led by a major U.S. public retirement system to advance genTRU-breast, an RNA-powered blood test for earlier breast cancer detection in women with dense breast tissue.
Roughly half of women have dense breast tissue, where both dense tissue and tumors appear white on mammograms – meaning the scan can miss cancer up to 70% of the time in women with extremely dense breasts. Since September 2024, a federal mandate requires imaging centers to notify women when their breasts are dense, creating a large newly informed population facing the same question: now what? The current answer routes them into supplemental ultrasound, MRI, and frequently biopsy – a pathway Mammogen estimates costs $11 billion a year, with the vast majority of biopsies coming back negative.
GenTRU-breast is designed as a triage tool after mammography flags dense tissue. A low result lets a woman avoid some supplemental imaging and likely an unnecessary biopsy. A high result sends her to MRI to characterize a suspected cancer before biopsy.
“The biggest difference we make by detecting disease early is offering optionality in treatment,” said CEO Elizabeth Cormier-May. “That could be everything from needing a mastectomy to not needing one, because we caught it at stage 1 or earlier.” She also noted that early detection gives patients of childbearing age the opportunity to consult with reproductive endocrinologists before treatment.
The company received CLIA validation of the assay in 2023 across six independent cohorts totaling more than 500 patients. An IRB-approved pivotal study is now enrolling using a hybrid decentralized design that can send phlebotomists to participants’ homes.
